Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
43537–43560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2012
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
K121422 · IYO
Toshiba Medical Systems Coporation,...
Radiology · 94d
Cleared Aug 16, 2012
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K121548 · HRX
Spine View, Inc.
Orthopedic · 83d
Cleared Aug 16, 2012
RESPROCESSED SERFAS ENERGY PROBE
K121855 · NUJ
Stryker Sustainability Solutions
General & Plastic Surgery · 52d
Cleared Aug 16, 2012
VITEK 2 AST-ST CEFOTAXIME
K121863 · LON
bioMerieux, Inc.
Microbiology · 51d
Cleared Aug 16, 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
K122182 · MQB
Rayence Co., Ltd.
Radiology · 24d
Cleared Aug 16, 2012
OEC 9900 ELITE
K122234 · OWB
Ge Healthcare Surgery GE Oec Medical...
Radiology · 21d
Cleared Aug 16, 2012
BIOJET
K122329 · LLZ
Jet Soft Srl
Radiology · 15d
Cleared Aug 15, 2012
ALTOMEC ARTHROSCOPE
K112548 · HRX
Altomec Endoscopy, Inc.
Orthopedic · 349d
Cleared Aug 15, 2012
GID 700
K120902 · MUU
The Gid Group, Inc.
General & Plastic Surgery · 142d
Cleared Aug 15, 2012
ARMADA 14XXT PTA CATHETER
K121352 · DQY
Abbott Vascular
Cardiovascular · 103d
Cleared Aug 15, 2012
4CIS VANE SPINE SYSTEM
K121615 · MNI
Solco Biomedical Co., Ltd.
Orthopedic · 75d
Cleared Aug 15, 2012
MOVATION KNEE SYSTEM
K121727 · OIY
Encore Medical, L.P.
Orthopedic · 64d
Cleared Aug 15, 2012
VISI MOBILE MONITORING SYSTEM
K122036 · MWI
Sotera Wireless, Inc.
Cardiovascular · 35d
Cleared Aug 15, 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE...
K122070 · LIT
Trireme Medical, Inc.
Cardiovascular · 30d
Cleared Aug 15, 2012
EXINI
K122205 · LLZ
Exini Diagnostics AB
Radiology · 21d
Cleared Aug 14, 2012
C100 WRINKLE REDUCTION DEVICE
K112362 · OHS
Silver Bay, LLC
General & Plastic Surgery · 363d
Cleared Aug 14, 2012
BIOHARNESS
K113045 · MHX
Zephyr Technology Corporation
Cardiovascular · 306d
Cleared Aug 14, 2012
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
K120158 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 209d
Cleared Aug 14, 2012
CONNECTED CARE CLINICAL APPLICATION
K120320 · DXN
Watermark Medical, Inc.
Cardiovascular · 194d
Cleared Aug 14, 2012
EXACTRAC X-RAY X-RAY
K120789 · IYE
Brainlab AG
Radiology · 152d
Cleared Aug 14, 2012
VARIOECO
K121334 · NHA
Thommen Medical AG
Dental · 103d
Cleared Aug 14, 2012
DYNAFLEX
K121396 · NXC
Dyna Flex
Dental · 97d
Cleared Aug 14, 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776 · DQX
Codman & Shurtleff, Inc.
Cardiovascular · 57d
Cleared Aug 14, 2012
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
K122126 · JIS
Randox Laboratories Limited
Chemistry · 27d